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Hep C Discussion Forum -> Hep C News -> 3 Die After Being Administered Sovriad (simeprevir sodium) Hepatitus C Drug
Post Info TOPIC: 3 Die After Being Administered Sovriad (simeprevir sodium) Hepatitus C Drug
Isiscat2011


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RE: 3 Die After Being Administered Sovriad (simeprevir sodium) Hepatitus C Drug
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The Japanese population experiences increased absorption of Olysio according to the manufacturer's representations at the FDA approval hearings.  They also tend to have more severe side effects.

Having said that these new DAAs are all experimental drugs in terms of real world results.  The FDA approved combos have been tested on more people but there is always a risk.  I'd be willing to bet there have been US deaths as well; we already know there have been a few linked to Sovaldi. Pharma is able to keep negative information under wraps quite well here.  Hopefully patients understand there are always potential risks and potential benefits and they are able to weigh them accordingly.  



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Diagnosed in 2011, Incivek triple in 2011, tx discontinued, Genotype 1a, CT, VL 7mill, cirrhosis dx in 2012, age 67, waiting for new DAAs.
OldenSlow


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Some case details on two of the three Japanese patients:

http://www.pmda.go.jp/english/service/pdf/letter/141024-sovriad_casereport.pdf

Relevant article:

http://seekingalpha.com/instablog/6062141-csyj/3405145-simeprevir-killing-patients-in-japan

While this is certainly not good news for the Janssen gang, I'd like to point out that there were 3 deaths out of 18900 patients. That would be about 0.016%. The odds of being struck by lightening in one's lifetime are roughly 1/12000.



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66 y/o male - Geno 1b - F4 cirrhotic dx 2001 - 16 wk treatment w/ Sovaldi/Olysio/Riba - Und @ EOT+24 SVR

 
Cinnamon Girl


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Hi Brownie, this article sounds very alarming at first glance but I think we all have to bear in mind that any drug comes with potentially serious associated risks, however small they may be.  And although it`s very scary to think that anyone would die while on tx we have to remember that Olysio has been taken by thousands and thousands of people already with minimal side effects for the vast majority, and in fact it has helped many people to rid themselves of Hep C, which can be life threatening in itself.  Another thing to consider is that we don`t have any detailed information on the exact causes of these unfortunate deaths or on any other health issues they might have had. 

My personal opinion is that we need to see it in a broader perspective.

Thanks for posting it, but I wouldn`t want anyone currently on tx or considering treatment with Olysio to be put off by this article!



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Jill 

(71 yo, lives in UK)

Was Gen 3a, 

24wks Peg Ifn/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 
Brownie


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This is OLYSIO !

3 die after being administered hepatitis C drug

The health ministry said Friday three people have died after taking the hepatitis C drug Sovriad, and it has ordered the distributor to revise the drug packaging to say usage should stop when indicated by a patient blood test.

The ministry also ordered the maker and distributor, Janssen Pharmaceutical K.K., to notify doctors and hospitals in writing of the change.

The package insert already warns of possible deterioration of liver function from use of the drug, known generically as Simeprevir Sodium. The ministry directed the packaging also say usage should be discontinued if a blood test indicates certain abnormalities.

According to the Ministry of Health, Labor and Welfare, taking the drug will increase "bilirubin" by decomposing hemoglobin in the blood and may aggravate dysfunction of the liver and kidney. 

Three patients in their 40s to 60s who were taking the drug died in connection with such symptoms, it said.

Since the drug was put on sale last December, about 19,000 people in Japan had used it by the end of September.

 

 

 



-- Edited by Brownie on Monday 27th of October 2014 06:40:16 PM



-- Edited by Brownie on Monday 27th of October 2014 06:41:00 PM



-- Edited by Brownie on Monday 27th of October 2014 08:39:01 PM

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